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Recombinant activated factor VII (rFVIIa) is an effective haemostatic agent in approximately 90 of patients with hemophilia and inhibiting antibodies, and in other types of complex coagulation disorders [1,2]. It has also been used in patients with a normal coagulation system, who experience serious bleeding. For these other patients,sound evidence from controlled clinical trials is only scarcely available so far. According to a recent systematic review, rFVIIa appears to be relatively safe with a 1? incidence of thrombotic complications based on published trials [3]. The main safety outcome in a recent trial on the use of rFVIIa in cerebral haemorrhage was severe thromboembolism at 90 days [4]; severe arterial andPage 1 of(page number not for citation purposes)Thrombosis Journal 2006, 4:http://www.thrombosisjournal.com/content/4/1/venous thromboembolic adverse events were more than three times as common in the rFVIIa groups as in the placebo group (7 percent vs. 2 percent), including seven myocardial infarctions and nine cerebral infarctions (for a combined rate of 5 percent). In the placebo group of this study, no arterial thromboembolic events were observed. In patients with fulminant hepatic failure, rFVIIa was used after conventional means for treating the associated coagulopathy had failed [5]; in these patients, rFVIIa corrected the coagulation defect, but thrombotic complications occurred in two of the four patients (myocardial ischemia and portal.